James H Liu1, Ken N Muse. 1. Department of Obstetrics and Gynecology, University of Cincinnati School of Medicine, Cincinnati, Ohio, USA. james.liu@uhhs.com
Abstract
OBJECTIVE: The purpose of this study was to evaluate the action of progestins on bone metabolism in early menopausal women. STUDY DESIGN:One hundred thirty-two menopausal women were randomized into a 2-year double-blinded, placebo-controlled clinical trial. There were 6 treatment groups: micronized progesterone (P 4 ) 300 mg/day; medroxyprogesterone acetate (MPA) 10 mg/day; norethindrone (NET) 1 mg/day; micronized estradiol (E 2 ) 1 mg/day; E 2 1 mg/day + MPA 10 mg/day; and placebo. All subjects received 1000 mg of calcium and 400 IU of vitamin D/day. Primary outcome variables were bone mineral density (BMD) changes at the spine and hip. Secondary variables were bone turnover markers. RESULTS: With E 2 or E 2 +MPA treatment, BMD at L2-L4 increased by 2% to 4% over 2 years. Bone mineral density (BMD) at the spine followed a decreasing trend with MPA, P 4 , and placebo treatments. With NET treatment, BMD did not change from baseline. At the femoral neck site, BMD did not change significantly for any treatment group. Bone resorption and bone formation markers decreased with E 2 or E 2 +MPA treatment, and did not change appreciably with all 3 progestin-alone treatments. There were no vertebral or hip fractures observed during the trial. CONCLUSION: Estrogen remains the primary bone active agent in hormone therapy, while progestins have significantly less activity. The selection of the appropriate progestin in hormone therapy should be based on criteria other than bone activity.
RCT Entities:
OBJECTIVE: The purpose of this study was to evaluate the action of progestins on bone metabolism in early menopausal women. STUDY DESIGN: One hundred thirty-two menopausal women were randomized into a 2-year double-blinded, placebo-controlled clinical trial. There were 6 treatment groups: micronized progesterone (P 4 ) 300 mg/day; medroxyprogesterone acetate (MPA) 10 mg/day; norethindrone (NET) 1 mg/day; micronized estradiol (E 2 ) 1 mg/day; E 2 1 mg/day + MPA 10 mg/day; and placebo. All subjects received 1000 mg of calcium and 400 IU of vitamin D/day. Primary outcome variables were bone mineral density (BMD) changes at the spine and hip. Secondary variables were bone turnover markers. RESULTS: With E 2 or E 2 +MPA treatment, BMD at L2-L4 increased by 2% to 4% over 2 years. Bone mineral density (BMD) at the spine followed a decreasing trend with MPA, P 4 , and placebo treatments. With NET treatment, BMD did not change from baseline. At the femoral neck site, BMD did not change significantly for any treatment group. Bone resorption and bone formation markers decreased with E 2 or E 2 +MPA treatment, and did not change appreciably with all 3 progestin-alone treatments. There were no vertebral or hip fractures observed during the trial. CONCLUSION: Estrogen remains the primary bone active agent in hormone therapy, while progestins have significantly less activity. The selection of the appropriate progestin in hormone therapy should be based on criteria other than bone activity.
Authors: Chrysoula G Liakou; George Mastorakos; Konstantinos Makris; Ioannis G Fatouros; Alexandra Avloniti; Helen Marketos; Julia D Antoniou; Antonios Galanos; Ismene Dontas; Demetrios Rizos; Symeon Tournis Journal: Endocrine Date: 2016-09-06 Impact factor: 3.633
Authors: Zhendong A Zhong; Alexander Kot; Yu-An E Lay; Hongliang Zhang; Junjing Jia; Nancy E Lane; Wei Yao Journal: J Bone Miner Res Date: 2017-07-13 Impact factor: 6.741
Authors: J C Prior; V R Seifert-Klauss; D Giustini; J D Adachi; S Kalyan; A Goshtasebi Journal: J Musculoskelet Neuronal Interact Date: 2017-09-01 Impact factor: 2.041